Magseed Pro(R)/ Sentimag(R) Gen3
This study is testing a new system, Magseed Pro and Sentimag Gen3, to see if it's safe and effective for helping surgeons locate breast cancer and affected lymph nodes. Before surgery, a tiny marker (Magseed Pro) is placed in the area of concern. Then, during the operation, a special device (Sentimag Gen3) helps the surgeon pinpoint exactly where the marker, and therefore the abnormal tissue, is, making it easier to remove. This aims to make surgery more precise for patients needing breast cancer treatment or removal of suspicious lymph nodes. The study will involve 224 patients across different hospitals.
At a glance
What is this study about?
Imagine you have a small area in your breast or a lymph node (a tiny gland that's part of your body's defence system) that doctors need to remove. Sometimes these areas are very small or hard to feel, making them tricky for surgeons to find during an operation. This study is looking at a new way to make this process easier and more accurate.
It uses two main parts: a tiny marker called Magseed Pro, and a device called Sentimag Gen3. The Magseed Pro is a very small seed that a doctor places inside your breast or lymph node in the area that needs to be removed. It acts like a tiny beacon. Then, when you have your surgery, the Sentimag Gen3 device acts like a special detector. It can find exactly where that Magseed Pro is, guiding the surgeon to the right spot to remove the affected tissue.
The main goal of this study is to check if using the Magseed Pro and Sentimag Gen3 system is both safe for patients and does a good job of helping surgeons accurately remove breast lesions (which could be cancer or pre-cancerous cells) and suspicious lymph nodes. The hope is that this new method will make operations more precise for patients.
Key takeaways
- This study tests a new way to help surgeons find and remove breast cancer or affected lymph nodes more accurately.
- It uses a tiny, safe marker (Magseed Pro) and a special detection device (Sentimag Gen3).
- The goal is to see if this system is safe and effective.
- Participation involves having the marker placed before surgery and then removed during your operation.
- You must be 18 or older and need breast or lymph node surgery to be eligible.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, you need to be at least 18 years old and willing to give your permission to be part of the research. Crucially, you must be a patient who needs to have a specific area in your breast, or a lymph node under your arm, marked and removed during surgery.
There are also some reasons why you wouldn't be able to join. If you are pregnant, planning to become pregnant during the study, or are breastfeeding, you cannot take part. Also, if you have a known allergy to a material called Nitinol (which some medical devices are made from), or if you have an active infection in the area where the marker would be placed, you wouldn't be eligible. Lastly, if your doctor thinks there's any other medical reason or personal circumstance that would make it difficult or unsafe for you to participate, you might not be able to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you need surgery to remove a breast lump or a suspicious lymph node?
- Are you not currently pregnant, planning to be, or breastfeeding?
- Do you have no known allergy to Nitinol?
- Do you not have an active infection at the site where the marker would be placed?
What does participation involve?
If you join this study, a tiny marker, called the Magseed Pro, will be placed in your breast or lymph node before your surgery. This is done to mark the area that needs to be removed. During your operation, the surgeon will use a special device (the Sentimag Gen3 system) to locate this marker and help them accurately remove the marked tissue.
The study involves about 224 patients in total. Your personal involvement would typically last anywhere from about 1 week up to 38 weeks after you join, depending on your treatment plan and follow-up. The main focus is on the placement of the marker, its use during surgery, and then your recovery. You won't need to take any special medication for this study.
Potential risks and benefits
Locations (6)
- Marienhospital Bottrop GmbHVerified postcodeBottrop, Germany· Recruiting
- AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbHVerified postcodeFrankfurt, Germany· Recruiting
- Technical University MunichVerified postcodeMunich, Germany· Not yet recruiting
- Guy's HospitalVerified postcodeLondon, United Kingdom· Recruiting
- Royal Marsden HospitalVerified postcodeLondon, United Kingdom· Recruiting
- University Hospital South ManchesterVerified postcodeManchester, United Kingdom· Recruiting
Common questions
What is a Magseed Pro?
It's a very tiny marker, like a small bead, that helps surgeons find specific spots in your body during an operation.
How is the marker put in?
It's usually placed by a doctor using a needle, similar to a biopsy, in the area that needs to be marked.
Will I feel the marker inside me?
Most people do not feel the marker once it's placed, as it's very small.
What is the Sentimag Gen3 system?
This is a special device that doctors use during surgery to detect the Magseed Pro marker, helping them find the exact area to operate on.
Does this study replace my normal treatment?
No, this study is about a tool used during your planned surgery; it's not a replacement for your prescribed cancer treatment.
How to find out more
Matt Womack, Dr
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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